"You take 10 parts and have 3 operators measure each 2
This standard approach to a Gage R&R experiment is so
common, so accepted, so ubiquitous that few people ever question
whether it is effective. Obviously one could look at whether
3 is an adequate number of operators or 2 an adequate number of
replicates, but in this first of a series of posts about
"Gauging Gage," I want to look at... Continue Reading
In its industry guidance to companies that manufacture drugs and
biological products for people and animals,
the Food and Drug Administration (FDA) recommends three stages for
Process Qualification, and Continued Process Verification. In
this post, we we will focus on that third stage.
Stage 3: Continued Process Verification
Per the FDA guidelines, the goal of... Continue Reading
Process validation is vital to the success of companies that
manufacture drugs and biological products for people and animals.
According to the FDA guidelines published by the U.S. Department of
Health and Human Services:
“Process validation is defined as
the collection and evaluation of data, from the process design
state through commercial production, which establishes scientific
evidence that a... Continue Reading
The line plot is an incredibly
agile but frequently overlooked tool in the quest to better
understand your processes.
In any process, whether it's baking a cake or processing loan
forms, many factors have the potential to affect the outcome.
Changing the source of raw
materials could affect the strength of plywood a factory produces.
Similarly, one method of gluing this plywood might be better... Continue Reading
The ultimate goal of most quality improvement projects is clear:
reducing the number of defects, improving a response, or making a
change that benefits your customers.
We often want to jump right in and start gathering and analyzing
data so we can solve the problems. Checking your measurement
systems first, with methods like attribute agreement analysis or
Gage R&R, may seem like a needless waste... Continue Reading
We’ve got a plethora of case studies showing how businesses from different
industries solve problems and implement solutions with data
analysis. Take a look for ideas about how you can use data analysis
to ensure excellence at your business!
Boston Scientific, one of the world’s leading developers of
medical devices, is just one organization who has shared their
story. A team at their Heredia,... Continue Reading
There may be huge potential benefits waiting in the data in your
servers. These data may be used for many different purposes. Better
data allows better decisions, of course. Banks, insurance firms,
and telecom companies already own a large amount of data about
their customers. These resources are useful for building a more
personal relationship with each customer.
Some organizations already use... Continue Reading
If you're just getting started in the world of quality
improvement, or if you find yourself in a position where you
suddenly need to evaluate the quality of incoming or outgoing
products from your company, you may have encountered the term
"acceptance sampling." It's a statistical method for evaluating the
quality of a large batch of materials from a small sample of items,
Whatever industry you're in, you're going to need to buy
supplies. If you're a printer, you'll need to purchase inks,
various types of printing equipment, and paper. If you're in
manufacturing, you'll need to obtain parts that you don't make
But how do you know you're making the right choice when you have
multiple suppliers vying to fulfill your orders? How can you
be sure you're... Continue Reading
by Erwin Gijzen, Guest
People who work in quality improvement know that the root causes
of quality issues are hard to find. A typical production process
can contain hundreds of potential causes. Additionally, companies
often produce products with multiple quality requirements, such as
dimensions, surface appearance, and impact resistance.
With so many variables, it’s no wonder many companies... Continue Reading
Cp and Cpk are well known capability indices commonly
used to ensure that a process spread is as small as possible
compared to the tolerance interval (Cp), or that it stays well
within specifications (Cpk).
Yet another type of capability index exists: the Cpm, which is
much less known and used less frequently. The main difference
between the Cpm and the other capability indices is that the... Continue Reading
In technical support, we frequently receive calls from Minitab
users who have questions about the differences between Cpk and
Michelle Paret already wrote a great post about the
differences between Cpk and Ppk, but it also helps to have a
better understanding of the math behind these numbers. So in this
post I will show you how to calculate Ppk using Minitab’s default
settings when the... Continue Reading
Suppose that you plan to source a substantial amount of parts or
subcomponents from a new supplier. To ensure that their quality
level is acceptable to you, you might want to assess the capability
and Cpk indices) of their manufacturing processes and check
whether their critical process parameters are fully under control
control charts). If you are not sure about the efficiency... Continue Reading
Parts 1 and
2 of Gauging Gage we looked at the numbers of parts, operators,
and replicates used in a Gage R&R Study and how accurately we
could estimate %Contribution based on the choice for each. In
doing so, I hoped to provide you with valuable and interesting
information, but mostly I hoped to make you like me. I mean
like me so much that if I told you that you were doing... Continue Reading
In Part 1 of Gauging Gage, I looked at how adequate a
sampling of 10 parts is for a Gage R&R Study and providing
some advice based on the results.
Now I want to turn my attention to the other two factors in the
standard Gage experiment: 3 operators and 2 replicates.
Specifically, what if instead of increasing the number of parts in
the experiment (my previous post demonstrated you would need... Continue Reading
frequently asked whether Minitab has been validated by the U.S.
Food and Drug Administration (FDA) for use in the pharmaceutical
and medical device industries.
Minitab does extensive testing to validate our software
internally, but Minitab’s statistical software
is not—and cannot be—FDA-validated out-of-the-box.
It is a common misconception that software vendors can go
through a... Continue Reading
a customer called our Technical Support team about a Design of Experiment he
was performing in Minitab Statistical Software. After they helped
to answer his question, the researcher pointed our team to an
interesting DOE he and his colleagues conducted that involved using
nasal casts to predict the drug delivery of nasal spray.
The study has already been published, and you can read... Continue Reading
processes are affected by various
sources of variations over time. Products which are designed
based on optimal settings, will, in reality, tend to drift away
from their ideal settings during the manufacturing process.
Environmental fluctuations and process variability often cause
major quality problems. Focusing only on costs and performances is
not enough. Sensitivity to deterioration and... Continue Reading
When I talk to quality professionals about how they use
statistics, one tool they mention again and again is design of
experiments, or DOE. I'd never even heard the term before I started
getting involved in quality improvement efforts, but now that I've
learned how it works, I wonder why I didn't learn about it sooner.
If you need to find out how several factors are affecting a process
outcome,... Continue Reading
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